Agencies throughout the United States are calling for an immediate pause on the distribution of the Johnson & Johnson (J&J) COVID-19 vaccine.
In a joint statement issued early Tuesday, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) say experts are reviewing data showing six cases of a “rare and severe” type of blood clot.
All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
As of Monday, more than 6.8 million doses of the J&J vaccine have been administered, says the CDC.
The CDC will hold a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, and the FDA will review their findings as it continues to investigate the cases.
Pfizer and Moderna vaccines are not included in the CDC’s and FDA’s recommended pause and continue to be viewed as safe to distribute, according to available information.
State officials are following the J&J cases closely. Ohio Gov. Mike DeWine, Ohio Department of Health Director Stephanie McCloud and Ohio Department of Health Chief Medical Officer Bruce Vanderhoff, M.D., are advising all vaccine providers in Ohio to temporarily pause distributing the vaccine.
Kentucky Gov. Andy Beshear will hold a media briefing Tuesday to address the situation.
Local governments also are determining their courses of action. Tuesday afternoon, Hamilton County Health Commissioner Greg Kesterman will discuss how the J&J pause may affect vaccine efforts within the county.
The CDC and FDA urges caution for anyone who received the J&J vaccine recently.
Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.
Johnson & Johnson has responded to concerns, as reported by ABC News.
"We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines," says the corporation. "At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine. We continue to work closely with experts and regulators to assess the data and support the open communication of this information to healthcare professionals and the public."
The CDC asks health care providers to report adverse events to the Vaccine Adverse Event Reporting System at vaers.hhs.gov/reportevent.html.
This is a developing story.